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A randomized clinical trial of
technical modifications of appendix
stump closure during laparoscopic
appendectomy for uncomplicated
acute appendicitis
Author information
Peter Ihnát, Milan Tesař, Lubomír Tulinský, Lucia Ihnát
Rudinská, Okaikor Okantey & Štefan Durdík
Department of Surgery,Department of Forensic
Medicine,Department of Cardiovascular
Surgery,Department of Oncosurgery
BMC Surg 21
Article no.- 272 (2021)
Published on- 31 May 2021
Introduction
 reduced postoperative pain
 faster recovery
 better cosmetic results
 reduced wound infection rate
• Closure of the appendix stump presents the most critical
part of Lap Appendectomy
• Several technical modifications of stump closure during Lap
Appendectomy are currently available
 closure with a clip(Hem-o-lok)
 closure with a endoloop
 Stapler
The aim of the this clinical trial was to
compare
1. medical outcomes
2. cost of laparoscopic appendectomy
Design and setting
Material and methods
 Prospective randomized clinical trial
 Conducted in the University Hospital Ostrava,
Czech Republic
 Study period :1st January 2018–31st December
2019
exclusion criteria were
1. Peroperative findings of necrosis
2. Advanced inflammatory changes in the
area of the appendix stump
3. Conversion to laparotomy due to diffuse
peritonitis
1. Age ≥ 18 years
2. Clinical signs of acute appendicitis
3. suitability for laparoscopic surgery
 inclusion criteria were
Each study subject was randomized(by
envelope method) to one of
3 trial arms
1. endoloop
2. Hem-o-lok
3. stapler
 Trial sample size - 180 patients(60 in each trail)
 Primary outcome measures of the study
1. Operative time
2. Intraoperative complications
3. Postoperative complications
 Economical outcome – secondary outcome measure
Surgical technique
• Lap Appendectomy was performed by certified surgeons
experienced in advanced laparoscopic surgery
• Surgery was performed under general anaesthesia
• Patient was placed in the supine, Trendelenburg position
• 3-port technique
1. 10-mm camera port in periumbilical region
2. 5-mm port in the left lower quadrant
3. 10-mm port in suprapubic region
• Mesoappendix was dissected using a harmonic
scalpel.
 In the first group
Appendix base was secured using a total of three vicryl endoloops (two loops
on the appendix base and one on the distal part which would be removed).
 In the second group
Three Hem-o-lok clips were used to secure the appendix base (two clips on the
appendix base and one on the distal part of the appendix)
 In the third group
The 10-mm port in a suprapubic region was changed to a 12-mm port and the
appendix base was dissected by means of a 45 mm stapling device
Results
 Mean age of study patients was 35.8 ± 16.9 years
 103 (57.2%) women and 77 (42.8%) men
 Mean BMI was 25.7 ± 4.2 kg/m2
 Mean operative time was 42.0 ± 13.0 min [ shortest with
hem-o-lok subgroup of patients (37.9 ± 12.5 min)]
 Mean length of hospital stay (3.6 ± 1.7 days)
 7 (11.7%) intraoperative complications in the stapler subgroup (bleeding
from the stapler line)
 No intraoperative complications were noted in the endoloop and hem-o-
lok subgroups.
 postoperative complications was manifested in 6.1%(11 patients)
• 8 Superficial SSI
• 3 Deep SSI
Highest costs- Stapler
Lowest costs- Hem-o- lok
Discussion
 Lap Appendectomy presents the preferred surgical technique for the
treatment of acute appendicitis
 Advantages are-
 better exploration of the abdominal/pelvic cavity
 reduced surgical trauma
 faster recovery rates
 better cosmetic results
 All Lap Appendectomy were performed by certified laparoscopic
surgeons(experienced in all three techniques of appendix
stump closure) in all the study patients
 There were statistically significant differences in clinical
parameters between the study subgroups
 age
 BMI
 Type of appendicitis
 Patients in the stapler subgroup were older
 Patients in the hem-o-lok subgroup had the highest BMI
 Patients in the stapler subgroup has phlegmonous appendicitis
 Postoperative surgical complications after Lap Appendectomy
was very low in all the study subgroups,may be due to
 many young patients with minimal co-morbidities
 very minimal surgical trauma during Lap Appendectomy
 The technique of appendix stump closure has an impact
on postoperative complications
 endoloop technique-risk of leaving the knot loose
 Appendix stump closure with clips (metal, plastic, absorbable
polymeric) may be limited by
1. diameter of appendix base
2. risk of clip opening and sliding off
 endostapler is more comfortable- but Costly
Therefore hem-o-lok clips seem to be a
reasonable solution,as
1. Securing the appendix stump with a minimal risk of sliding off
2. Technically easy
3. Cost-effective
4. Shortest operative time(may be due to uneven distribution of
severe inflammations between the study subgroups)
 One of the most important prospective studies focused
on the different techniques of appendix stump closure
was published recently by Delibegović et al
 The design of the study was similar to this Study ( 30
in each arm)
 Zero postoperative morbidity in study patients and
confirmed equality of the different techniques
Matyja et al. compared appendix stump closure by
means of a
 clip
 stapler
 laparoscopic suture
 20 patients in each study arm
No differences in postoperative morbidity
 Muñoz-Cruzado et al. conducted a retrospective cohort
study of 709 patients undergoing Lap Appendectomy
with different techniques of appendix stump closure
 No differences in postoperative complications
between patients with uncomplicated appendicitis
 Complicated appendicitis
 higher postoperative morbidity
 higher number of reoperations
in endoloop subgroup compared to stapler subgroup
 Polish multicenter cohort study
 1269 patients from 18 surgical unites
 Superior outcomes of endostapler in terms of
 overall postoperative morbidity
 length of hospital stay
 Different techniques of appendix stump closure
have been carefully analyzed also in the 2020
update of the WSES (World Society of Emergency
Surgery) Jerusalem Guidelines
 No clinical advantages in the use of endostaplers over
endoloops for stump closure for both adults and
children in either simple or complicated appendicitis
 Lower incidence of wound infection when using
endostaplers in children with uncomplicated
appendicitis.
Conclusion
 Lap Appendectomy presents a well-established surgical
technique in the treatment of acute appendicitis
 Operative time is significantly longer when the endoloop
is employed for stump closure
 Stapler technique is significantly the most expensive
 Taking all these facts into account, hem-o-lok clips seem
to have the potential for becoming the preferred method
of securing the appendix base during Lap Appendectomy
References
1. Ohtani H, Tamamori Y, Arimoto Y, Nishiguchi Y, Maeda K, Hirakawa K. Meta-analysis of the results of randomized
controlled trials that compared laparoscopic and open surgery for acute appendicitis. J Gastrointest Surg.
2012;16:1929–39.
2. National Surgical Research Collaborative. Multicentre observational study of performance variation in provision
and outcome of emergency appendicectomy. Br J Surg. 2013;100:1240–52.
3. McCoy AC, Gasevic E, Szlabick RE, Sahmoun AE, Sticca RP. Are open abdominal procedures a thing of the past?
An analysis of graduating general surgery residents’ case logs from 2000 to 2011. J Surg Educ. 2013;70:683–9.
4. Li X, Zhang J, Sang L, Zhang W, Chu Z, Li X, et al. Laparoscopic versus conventional appendectomy—a meta-
analysis of randomized controlled trials. BMC Gastroenterol. 2010;10:129.
5. Dai L, Shuai J. Laparoscopic versus open appendectomy in adults and children: a meta-analysis of randomized
trials. United Eur Gastroenterol J. 2017;4:542–53.
6. Sauerland S, Jaschinski T, Neugebauer EA. Laparoscopic versus open surgery for suspected appendicitis.
Cochrane Database Syst Rev. 2010;6:CD001546.
7. Guller U, Hervey S, Purves H, Muhlbaier LH, Peterson ED, Eubanks S, et al. Laparoscopic versus open
appendectomy: outcomes comparison based on a large administrative database. Ann Surg. 2004;239:43–52.
8.Matyja M, Strzałka M, Rembiasz K. Laparoscopic appendectomy, cost-effectiveness of three different techniques used
to close the appendix stump. Pol Przegl Chir. 2015;7(12):634–7.
9.Matyja M, Strzałka M, Rembiasz K. Laparoscopic appendectomy, cost-effectiveness of three different techniques used
to close the appendix stump. Pol Przegl Chir. 2015;7(12):634–7.
10.Costa-Navarro D, Jimenes-Fuertes M, Illian-Riquelme A. Laparoscopic appendectomy: quality care and cost
effectiveness for today’s economy. World J Emerg Surg. 2013;8(1):45.
11.Gomes CA, Junior CS, de Peixoto RO, Netto JM, Gomes CC, Gomes FC. Appendiceal stump closure by metal endoclip
in the management of complicated acute appendicitis. World J Emerg Surg. 2013;8:35.
12.Delibegović S, Mehmedovic Z. The influence of the different forms of appendix base closure on patient outcome in
laparoscopic appendectomy: a randomized trial. Surg Endosc. 2018;32(5):2295–9.
13.Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a
cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–13.
14.Guaitoli E, Gallo G, Cardone E, Conti L, Famularo S, Formisano G, et al. Consensus statement of the italian
polispecialistic society of young surgeons (SPIGC): diagnosis and treatment of acute appendicitis. J Invest Surg. 2020; 1–
15
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RCT on Base tie in laparoscopic appendecomy (Journal Club).pptx

  • 1. A randomized clinical trial of technical modifications of appendix stump closure during laparoscopic appendectomy for uncomplicated acute appendicitis
  • 2. Author information Peter Ihnát, Milan Tesař, Lubomír Tulinský, Lucia Ihnát Rudinská, Okaikor Okantey & Štefan Durdík Department of Surgery,Department of Forensic Medicine,Department of Cardiovascular Surgery,Department of Oncosurgery BMC Surg 21 Article no.- 272 (2021) Published on- 31 May 2021
  • 3. Introduction  reduced postoperative pain  faster recovery  better cosmetic results  reduced wound infection rate
  • 4. • Closure of the appendix stump presents the most critical part of Lap Appendectomy • Several technical modifications of stump closure during Lap Appendectomy are currently available  closure with a clip(Hem-o-lok)  closure with a endoloop  Stapler
  • 5. The aim of the this clinical trial was to compare 1. medical outcomes 2. cost of laparoscopic appendectomy
  • 6. Design and setting Material and methods  Prospective randomized clinical trial  Conducted in the University Hospital Ostrava, Czech Republic  Study period :1st January 2018–31st December 2019
  • 7. exclusion criteria were 1. Peroperative findings of necrosis 2. Advanced inflammatory changes in the area of the appendix stump 3. Conversion to laparotomy due to diffuse peritonitis 1. Age ≥ 18 years 2. Clinical signs of acute appendicitis 3. suitability for laparoscopic surgery  inclusion criteria were
  • 8. Each study subject was randomized(by envelope method) to one of 3 trial arms 1. endoloop 2. Hem-o-lok 3. stapler
  • 9.  Trial sample size - 180 patients(60 in each trail)  Primary outcome measures of the study 1. Operative time 2. Intraoperative complications 3. Postoperative complications  Economical outcome – secondary outcome measure
  • 10. Surgical technique • Lap Appendectomy was performed by certified surgeons experienced in advanced laparoscopic surgery • Surgery was performed under general anaesthesia • Patient was placed in the supine, Trendelenburg position • 3-port technique 1. 10-mm camera port in periumbilical region 2. 5-mm port in the left lower quadrant 3. 10-mm port in suprapubic region • Mesoappendix was dissected using a harmonic scalpel.
  • 11.  In the first group Appendix base was secured using a total of three vicryl endoloops (two loops on the appendix base and one on the distal part which would be removed).  In the second group Three Hem-o-lok clips were used to secure the appendix base (two clips on the appendix base and one on the distal part of the appendix)  In the third group The 10-mm port in a suprapubic region was changed to a 12-mm port and the appendix base was dissected by means of a 45 mm stapling device
  • 13.  Mean age of study patients was 35.8 ± 16.9 years  103 (57.2%) women and 77 (42.8%) men  Mean BMI was 25.7 ± 4.2 kg/m2
  • 14.
  • 15.  Mean operative time was 42.0 ± 13.0 min [ shortest with hem-o-lok subgroup of patients (37.9 ± 12.5 min)]  Mean length of hospital stay (3.6 ± 1.7 days)  7 (11.7%) intraoperative complications in the stapler subgroup (bleeding from the stapler line)  No intraoperative complications were noted in the endoloop and hem-o- lok subgroups.  postoperative complications was manifested in 6.1%(11 patients) • 8 Superficial SSI • 3 Deep SSI
  • 16.
  • 17. Highest costs- Stapler Lowest costs- Hem-o- lok
  • 18. Discussion  Lap Appendectomy presents the preferred surgical technique for the treatment of acute appendicitis  Advantages are-  better exploration of the abdominal/pelvic cavity  reduced surgical trauma  faster recovery rates  better cosmetic results
  • 19.  All Lap Appendectomy were performed by certified laparoscopic surgeons(experienced in all three techniques of appendix stump closure) in all the study patients  There were statistically significant differences in clinical parameters between the study subgroups  age  BMI  Type of appendicitis  Patients in the stapler subgroup were older  Patients in the hem-o-lok subgroup had the highest BMI  Patients in the stapler subgroup has phlegmonous appendicitis
  • 20.  Postoperative surgical complications after Lap Appendectomy was very low in all the study subgroups,may be due to  many young patients with minimal co-morbidities  very minimal surgical trauma during Lap Appendectomy  The technique of appendix stump closure has an impact on postoperative complications  endoloop technique-risk of leaving the knot loose  Appendix stump closure with clips (metal, plastic, absorbable polymeric) may be limited by 1. diameter of appendix base 2. risk of clip opening and sliding off  endostapler is more comfortable- but Costly
  • 21. Therefore hem-o-lok clips seem to be a reasonable solution,as 1. Securing the appendix stump with a minimal risk of sliding off 2. Technically easy 3. Cost-effective 4. Shortest operative time(may be due to uneven distribution of severe inflammations between the study subgroups)
  • 22.  One of the most important prospective studies focused on the different techniques of appendix stump closure was published recently by Delibegović et al  The design of the study was similar to this Study ( 30 in each arm)  Zero postoperative morbidity in study patients and confirmed equality of the different techniques
  • 23. Matyja et al. compared appendix stump closure by means of a  clip  stapler  laparoscopic suture  20 patients in each study arm No differences in postoperative morbidity
  • 24.  Muñoz-Cruzado et al. conducted a retrospective cohort study of 709 patients undergoing Lap Appendectomy with different techniques of appendix stump closure  No differences in postoperative complications between patients with uncomplicated appendicitis  Complicated appendicitis  higher postoperative morbidity  higher number of reoperations in endoloop subgroup compared to stapler subgroup
  • 25.  Polish multicenter cohort study  1269 patients from 18 surgical unites  Superior outcomes of endostapler in terms of  overall postoperative morbidity  length of hospital stay
  • 26.  Different techniques of appendix stump closure have been carefully analyzed also in the 2020 update of the WSES (World Society of Emergency Surgery) Jerusalem Guidelines  No clinical advantages in the use of endostaplers over endoloops for stump closure for both adults and children in either simple or complicated appendicitis  Lower incidence of wound infection when using endostaplers in children with uncomplicated appendicitis.
  • 27. Conclusion  Lap Appendectomy presents a well-established surgical technique in the treatment of acute appendicitis  Operative time is significantly longer when the endoloop is employed for stump closure  Stapler technique is significantly the most expensive  Taking all these facts into account, hem-o-lok clips seem to have the potential for becoming the preferred method of securing the appendix base during Lap Appendectomy
  • 28. References 1. Ohtani H, Tamamori Y, Arimoto Y, Nishiguchi Y, Maeda K, Hirakawa K. Meta-analysis of the results of randomized controlled trials that compared laparoscopic and open surgery for acute appendicitis. J Gastrointest Surg. 2012;16:1929–39. 2. National Surgical Research Collaborative. Multicentre observational study of performance variation in provision and outcome of emergency appendicectomy. Br J Surg. 2013;100:1240–52. 3. McCoy AC, Gasevic E, Szlabick RE, Sahmoun AE, Sticca RP. Are open abdominal procedures a thing of the past? An analysis of graduating general surgery residents’ case logs from 2000 to 2011. J Surg Educ. 2013;70:683–9. 4. Li X, Zhang J, Sang L, Zhang W, Chu Z, Li X, et al. Laparoscopic versus conventional appendectomy—a meta- analysis of randomized controlled trials. BMC Gastroenterol. 2010;10:129. 5. Dai L, Shuai J. Laparoscopic versus open appendectomy in adults and children: a meta-analysis of randomized trials. United Eur Gastroenterol J. 2017;4:542–53. 6. Sauerland S, Jaschinski T, Neugebauer EA. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database Syst Rev. 2010;6:CD001546. 7. Guller U, Hervey S, Purves H, Muhlbaier LH, Peterson ED, Eubanks S, et al. Laparoscopic versus open appendectomy: outcomes comparison based on a large administrative database. Ann Surg. 2004;239:43–52.
  • 29. 8.Matyja M, Strzałka M, Rembiasz K. Laparoscopic appendectomy, cost-effectiveness of three different techniques used to close the appendix stump. Pol Przegl Chir. 2015;7(12):634–7. 9.Matyja M, Strzałka M, Rembiasz K. Laparoscopic appendectomy, cost-effectiveness of three different techniques used to close the appendix stump. Pol Przegl Chir. 2015;7(12):634–7. 10.Costa-Navarro D, Jimenes-Fuertes M, Illian-Riquelme A. Laparoscopic appendectomy: quality care and cost effectiveness for today’s economy. World J Emerg Surg. 2013;8(1):45. 11.Gomes CA, Junior CS, de Peixoto RO, Netto JM, Gomes CC, Gomes FC. Appendiceal stump closure by metal endoclip in the management of complicated acute appendicitis. World J Emerg Surg. 2013;8:35. 12.Delibegović S, Mehmedovic Z. The influence of the different forms of appendix base closure on patient outcome in laparoscopic appendectomy: a randomized trial. Surg Endosc. 2018;32(5):2295–9. 13.Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–13. 14.Guaitoli E, Gallo G, Cardone E, Conti L, Famularo S, Formisano G, et al. Consensus statement of the italian polispecialistic society of young surgeons (SPIGC): diagnosis and treatment of acute appendicitis. J Invest Surg. 2020; 1– 15