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A randomized clinical trial of
technical modifications of appendix
stump closure during laparoscopic
appendectomy for uncomplicated
acute appendicitis
Journal Club Presentation
Author information
Department of Surgery, University Hospital Ostrava, 17.listopadu 1790,
Ostrava, 708 52, Czech Republic
Peter Ihnát, Milan Tesař & Lubomír Tulinský
Department of Forensic Medicine, University Hospital Ostrava,
17.listopadu 1790, Ostrava, 708 52, Czech Republic
Lucia Ihnát Rudinská
Department of Cardiovascular Surgery, University Hospital Ostrava,
17.listopadu 1790, Ostrava, 708 52, Czech Republic
Okaikor Okantey
Department of Oncosurgery, Faculty of Medicine, Commenius
University Bratislava, Spitalska 24, Bratislava, 813 72, Slovakia
Lucia Ihnát Rudinská & Štefan Durdík
Received
04 December 2020
Accepted
25 May 2021
Published
31 May 2021
BMC Surg 21
Article number: 272 (2021).
 Prospective randomized clinical trial
 University Hospital Ostrava(Czech Republic)
 2-year study period
 Three trial arms
Introduction
 reduced postoperative pain
 faster recovery
 better cosmetic results
 reduced wound infection rate
• Closure of the appendix stump presents the most critical part of
L-APPE
• Several technical modifications of stump closure during L-APPE are
currently available
 closure with a clip(Hem-o-lok)
 closure with a endoloop
 Stapler
The aim of the this clinical trial was
1. compare 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
 inclusion criteria were
1. Age ≥ 18 years
2. Clinical signs of acute appendicitis
3. suitability for laparoscopic surgery
 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
Each study subject was randomized
to one of
3 trial arms
 endoloop
 Hem-o-lok
 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
Surgical technique
 L-APPE 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 on the distal
part of the appendix)
 In the third group
The 10-mm port in a suprapubic region was
changed for 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
 L-APPE 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
 faster recovery rates
 better cosmetic results
 All L-APPE 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 our 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 L-APPE was very
low in all the study subgroups,may be due to
 many young patients with minimal co-morbidities
 very minimal surgical trauma during L-APPE
 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.
Conclusion
 L-APPE 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 L-APPE.
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 lap appendecomy.pptx

  • 1. A randomized clinical trial of technical modifications of appendix stump closure during laparoscopic appendectomy for uncomplicated acute appendicitis Journal Club Presentation
  • 2. Author information Department of Surgery, University Hospital Ostrava, 17.listopadu 1790, Ostrava, 708 52, Czech Republic Peter Ihnát, Milan Tesař & Lubomír Tulinský Department of Forensic Medicine, University Hospital Ostrava, 17.listopadu 1790, Ostrava, 708 52, Czech Republic Lucia Ihnát Rudinská Department of Cardiovascular Surgery, University Hospital Ostrava, 17.listopadu 1790, Ostrava, 708 52, Czech Republic Okaikor Okantey Department of Oncosurgery, Faculty of Medicine, Commenius University Bratislava, Spitalska 24, Bratislava, 813 72, Slovakia Lucia Ihnát Rudinská & Štefan Durdík
  • 3. Received 04 December 2020 Accepted 25 May 2021 Published 31 May 2021 BMC Surg 21 Article number: 272 (2021).
  • 4.  Prospective randomized clinical trial  University Hospital Ostrava(Czech Republic)  2-year study period  Three trial arms
  • 5. Introduction  reduced postoperative pain  faster recovery  better cosmetic results  reduced wound infection rate
  • 6. • Closure of the appendix stump presents the most critical part of L-APPE • Several technical modifications of stump closure during L-APPE are currently available  closure with a clip(Hem-o-lok)  closure with a endoloop  Stapler
  • 7. The aim of the this clinical trial was 1. compare medical outcomes 2. Cost of laparoscopic appendectomy
  • 8. 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  inclusion criteria were 1. Age ≥ 18 years 2. Clinical signs of acute appendicitis 3. suitability for laparoscopic surgery
  • 9.  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
  • 10. Each study subject was randomized to one of 3 trial arms  endoloop  Hem-o-lok  stapler
  • 11.  Trial sample size - 180 patients(60 in each trail)  Primary outcome measures of the study 1. Operative time 2. Intraoperative complications 3. Postoperative complications
  • 12. Surgical technique  L-APPE 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.
  • 13.  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).
  • 14.  In the second group Three Hem-o-lok clips were used to secure the appendix base (two clips on the appendix base and on the distal part of the appendix)
  • 15.  In the third group The 10-mm port in a suprapubic region was changed for a 12-mm port and the appendix base was dissected by means of a 45 mm stapling device
  • 17.  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
  • 18.
  • 19.  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
  • 20.
  • 21. Highest costs- Stapler Lowest costs- Hem-o- lok
  • 22. Discussion  L-APPE 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  faster recovery rates  better cosmetic results
  • 23.  All L-APPE 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 our 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
  • 24.  Postoperative surgical complications after L-APPE was very low in all the study subgroups,may be due to  many young patients with minimal co-morbidities  very minimal surgical trauma during L-APPE  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
  • 25. 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.
  • 26. Conclusion  L-APPE 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 L-APPE.
  • 27. 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.
  • 28. 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