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The goal of this clinical trial is to compare approaches to enterostomy reversal by hand-sewn end-to-end anastomosis versus side-to-side anastomosis (sub-divided into hand-sewn side-to-side anastomosis and stapled side-to-side anastomosis). The main question it aims to answer is:
• If either of the approaches are better than the other with respect to success rates, efficacy, post-operative complications and overall morbidity.
Participants admitted for stoma reversal will be divided into two groups:
EE: Conventional Hand-sewn end-to-end anastomosis, and
SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups:
Researchers will compare the EE group to SS group overall, and a second comparison will be made between EE, HSSA and SSSA groups, to see:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EE | Active Comparator | End-to-end anastomosis, done in a conventionally described hand-sewn technique using sutures |
|
| SSSA | Active Comparator | Stapled side-to-side anastomosis of the stoma using a linear cutter stapling device |
|
| HSSA | Active Comparator | Hand-sewn anastomosis of the stoma using suturing of bowel loops placed in a side to side orientation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand sewn end-to-end anastomosis | Procedure | Hand sewn end-to-end anastomosis (EE) Holding sutures were taken through a seromuscular bite with PDS (Polydiaxonone) 3-0 or Silk 2-0 RB (Round Bodied needle), one each at the mesenteric and antimesenteric ends of the stoma. A posterior layer of Lembert sutures was taken first. The first bite was taken at the anti-mesenteric end and a knot was applied. A Connell stitch was applied at the corner and then the posterior layer was closed using an inverting interlocking continuous stitch till the mesenteric end. Another Connell stitch was applied here to secure the corner and the suture was continued on to the anterior layer which was then closed in a similar manner using a continuous interlocking stitch. The final bite crossed the initial knot and the final knot was applied. An anterior layer of Lembert sutures was taken to reinforce the anastomotic line. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Post-operative Ileus (POI) | Number of participants with two or more episodes of nausea/vomiting, inability to tolerate oral diet over 24 hours, absence of flatus over 24 hours, or distension, and with radiologic confirmation, occurring postoperatively without spontaneous resolution | From the day of surgery for 30 days |
| Number of participants with Anastomotic Leak | Number of participants with leakage of bowel contents from the anastomotic site, confirmed with imaging studies and clinical signs, such as fever >38.5ËšC, leucocytosis, elevated serum C-reactive protein, drainage of intestinal content from the drain or computed tomography findings of abscess formation around the anastomosis. | From the day of surgery for 30 days |
| Number of participants with complications of Clavien-Dindo grade higher than 2 | Number of participants with complications developing post-operatively of Clavien-Dindo grade higher than 2, suggestive of a severe complication. | From the day of surgery for 30 days |
| Number of participants with Bowel Obstruction | Number of participants with Bowel dilatation and obstipation (inability to pass flatus as well as motion), requiring surgery for treatment, with transition point of the obstruction confirmed either radiologically or intraoperatively | From the day of surgery for 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Operating Time | Time during surgery from incision to skin closure | Intraoperatively |
| Number of participants with Wound Infection | Number of participants with Infection of the incision site ranging from simple local purulent collection to overt infection requiring re-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Bowel Movement | number of days for patient to first pass flatus or first stool after surgery | From the day of surgery for 30 days |
| Days to Liquid diet | number of days for patient to be first started on and tolerate liquids given per-orally, without causing vomiting or abdominal distension |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sawai Mansingh Medical College and Hospital | Jaipur | Rajasthan | 302004 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Stedman's Medical Dictionary. 27th ed. Baltimore: Lippincott Williams & Wilkins; 2000. | ||
| Background | Turnbull RB, Weakley FL. St Louis: Mosby. Atlas of intestinal stomas. 1967;32-9. | ||
| 25396004 | Background | Dinc B, Ay N, Ciyiltepe H. Comparing methods of ileostomy closure constructed in colorectal surgery in Turkey. Prz Gastroenterol. 2014;9(5):291-6. doi: 10.5114/pg.2014.46165. Epub 2014 Oct 19. | |
| 30747626 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 17, 2023 | |
| Reset | Jan 3, 2024 | |
| Release | Jan 4, 2024 |
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two groups in parallel: EE and SS, and another comparison with three arms: EE versus SS divided into two separate arms: SSSA and HSSA
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|
| Hand sewn side-to-side anastomosis | Procedure | Hand sewn side-to-side anastomosis (HSSA) Each end of the stoma was closed using either a single layer of inverting interlocking continuous sutures with PDS 3-0 or Silk 2-0 RB, or a Linear Stapling device. The two closed stumps were then brought adjacent to each other in an anti-peristaltic arrangement. A posterior layer of Lembert sutures was applied using Silk 2-0 RB. The bowel wall was incised using electrocautery close to the suture line. The incision was lengthened up to a width of at least 5-6 cm. The posterior and anterior layer was now closed using the same technique as in HS using PDS 3-0. An anterior layer of Lembert sutures was applied. The mesenteric defect was then closed using a superficial interrupted layer of Silk 2-0 RB. |
|
| Stapled side-to-side anastomosis | Procedure | Stapled side-to-side anastomosis or Functional End-to-end anastomosis (SSSA/FEEA) The two limbs of a Linear Cutter SR55 are placed into the proximal and distal bowel loops of the stoma, facing as far away from the mesenteric border as possible and then fired. If both lumens are of similar size, traction sutures are applied with Silk 2-0 RB at the anterior and posterior termination ends of the staple line. The two ends are pulled away from each other, and a Linear Cutter SR75 is applied just below the edge of the bowel and fired. However, in case of an ileo-colostomy, after the first linear cutter SR55 is fired, the two suture lines are approximated in such a way that they do not get apposed but rather lie adjacent to each other. The lumen is then clamped in SR75 which is then fired. |
|
| From the day of surgery for 30 days |
| Number of participants with Anastomotic Bleeding | Number of participants with Evidence of bleeding around the anastomotic site, confirmed by a complaint of melena, or radiological or endoscopic findings. | From the day of surgery for 30 days |
| Number of participants with Anastomotic Stricture | Number of participants with Imaging studies done in patients with complaints of nausea or bloating after oral intake, demonstrating intestinal distension starting from oral side of the anastomotic site, occurring due to narrowing at the site of anastomosis due to any cause. This did not include patients unable to pass flatus and motion (obstipation, criteria for bowel obstruction) or patients only unable to tolerate oral diet without other symptoms (criteria for POI). | From the day of surgery for 30 days |
| Number of participants with Intra-abdominal Collection | Number of participants with fluid collection inside the abdominal cavity developing post-operatively, of any origin, which was not present before surgery. The fluid collection includes presence of ascitic fluid, blood or pus, in amount sufficient to be detected by an abdominal ultrasound or computed tomography imaging. The number of participants showing presence of fluid was measured, and not the volume of fluid. | From the day of surgery for 30 days |
| Number of participants with Re-operation | Number of participants developing complications severe enough and not responding to medical management, that needed to be re-operated | From the day of surgery for 30 days |
| Number of participants with Organ Dysfunction for each individual organ | Number of participants with Dysfunction in any organ, evidenced by symptoms and blood tests, developing post-operatively and not present before surgery. The outcome was measured as the number of participants developing dysfunction of each a particular organ system, labelled as Renal, Cardiac, Hepatic, Vascular and Respiratory. | From the day of surgery for 30 days |
| Overall Morbidity | The overall morbidity is reflective of the number of patients who have at least 1 complication; that is, patients who have at least 1 complication were counted only once, and only their highest-grade complication was counted, graded on the Clavien-Dindo scale. | From the day of surgery for 30 days |
| From the day of surgery for 30 days |
| Days to Solid diet | number of days for patient to be first started on and tolerate progressively increasing semi-solid diet given per-orally, without causing vomiting or abdominal distension | From the day of surgery for 30 days |
| Postoperative length of stay | Number of days for the patient to be discharged from the hospital without complications. | From the day of surgery for 30 days |
| Background |
| Prassas D, Ntolia A, Spiekermann JD, Rolfs TM, Schumacher FJ. Reversal of Diverting Loop Ileostomy Using Hand-Sewn Side-to-Side versus End-to-End Anastomosis after Low Anterior Resection for Rectal Cancer: A Single Center Experience. Am Surg. 2018 Nov 1;84(11):1741-1744. |
| 5687844 | Background | Steichen FM. The use of staplers in anatomical side-to-side and functional end-to-end enteroanastomoses. Surgery. 1968 Nov;64(5):948-53. No abstract available. |
| 25287418 | Background | Liu Z, Wang G, Yang M, Chen Y, Miao D, Muhammad S, Wang X. Ileocolonic anastomosis after right hemicolectomy for colon cancer: functional end-to-end or end-to-side? World J Surg Oncol. 2014 Oct 7;12:306. doi: 10.1186/1477-7819-12-306. |
| 20187520 | Background | Sameshima S, Koketsu S, Yoneyama S, Miyato H, Kaji T, Sawada T. Outcome of functional end-to-end anastomosis following right hemicolectomy. Int Surg. 2009 Jul-Sep;94(3):249-53. |
| 17285383 | Background | Goto T, Kawasaki K, Fujino Y, Kanemitsu K, Kamigaki T, Kuroda D, Suzuki Y, Kuroda Y. Evaluation of the mechanical strength and patency of functional end-to-end anastomoses. Surg Endosc. 2007 Sep;21(9):1508-11. doi: 10.1007/s00464-006-9131-6. Epub 2007 Feb 7. |
| 21901690 | Background | Choy PY, Bissett IP, Docherty JG, Parry BR, Merrie A, Fitzgerald A. Stapled versus handsewn methods for ileocolic anastomoses. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD004320. doi: 10.1002/14651858.CD004320.pub3. |
| 25539702 | Background | Loffler T, Rossion I, Goossen K, Saure D, Weitz J, Ulrich A, Buchler MW, Diener MK. Hand suture versus stapler for closure of loop ileostomy--a systematic review and meta-analysis of randomized controlled trials. Langenbecks Arch Surg. 2015 Feb;400(2):193-205. doi: 10.1007/s00423-014-1265-8. Epub 2014 Dec 25. |
| 23095628 | Background | Loffler T, Rossion I, Bruckner T, Diener MK, Koch M, von Frankenberg M, Pochhammer J, Thomusch O, Kijak T, Simon T, Mihaljevic AL, Kruger M, Stein E, Prechtl G, Hodina R, Michal W, Strunk R, Henkel K, Bunse J, Jaschke G, Politt D, Heistermann HP, Fusser M, Lange C, Stamm A, Vosschulte A, Holzer R, Partecke LI, Burdzik E, Hug HM, Luntz SP, Kieser M, Buchler MW, Weitz J; HASTA Trial Group. HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial): results of a multicenter randomized trial (DRKS00000040). Ann Surg. 2012 Nov;256(5):828-35; discussion 835-6. doi: 10.1097/SLA.0b013e318272df97. |
| 6379923 | Background | Chassin JL, Rifkind KM, Turner JW. Errors and pitfalls in stapling gastrointestinal tract anastomoses. Surg Clin North Am. 1984 Jun;64(3):441-59. doi: 10.1016/s0039-6109(16)43330-x. |
| 16897328 | Background | Perez RO, Habr-Gama A, Seid VE, Proscurshim I, Sousa AH Jr, Kiss DR, Linhares M, Sapucahy M, Gama-Rodrigues J. Loop ileostomy morbidity: timing of closure matters. Dis Colon Rectum. 2006 Oct;49(10):1539-45. doi: 10.1007/s10350-006-0645-8. |
| 18590670 | Background | Flikier-Zelkowicz B, Codina-Cazador A, Farres-Coll R, Olivet-Pujol F, Martin-Grillo A, Pujadas-de Palol M. [Morbidity and mortality associated with diverting ileostomy closures in rectal cancer surgery]. Cir Esp. 2008 Jul;84(1):16-9. doi: 10.1016/s0009-739x(08)70598-0. Spanish. |
| 22752281 | Background | Hiranyakas A, Rather A, da Silva G, Weiss EG, Wexner SD. Loop ileostomy closure after laparoscopic versus open surgery: is there a difference? Surg Endosc. 2013 Jan;27(1):90-4. doi: 10.1007/s00464-012-2422-1. Epub 2012 Jun 30. |
| 24035923 | Background | Klink CD, Wunschmann M, Binnebosel M, Alizai HP, Lambertz A, Boehm G, Neumann UP, Krones CJ. Influence of skin closure technique on surgical site infection after loop ileostomy reversal: retrospective cohort study. Int J Surg. 2013;11(10):1123-5. doi: 10.1016/j.ijsu.2013.09.003. Epub 2013 Sep 12. |
| 2403907 | Background | Livingston EH, Passaro EP Jr. Postoperative ileus. Dig Dis Sci. 1990 Jan;35(1):121-32. doi: 10.1007/BF01537233. |
| 18071833 | Background | Leung TT, MacLean AR, Buie WD, Dixon E. Comparison of stapled versus handsewn loop ileostomy closure: a meta-analysis. J Gastrointest Surg. 2008 May;12(5):939-44. doi: 10.1007/s11605-007-0435-1. Epub 2007 Dec 11. |
| 16256921 | Background | Kaidar-Person O, Person B, Wexner SD. Complications of construction and closure of temporary loop ileostomy. J Am Coll Surg. 2005 Nov;201(5):759-73. doi: 10.1016/j.jamcollsurg.2005.06.002. Epub 2005 Sep 6. No abstract available. |
| 22340709 | Background | Fauno L, Rasmussen C, Sloth KK, Sloth AM, Tottrup A. Low complication rate after stoma closure. Consultants attended 90% of the operations. Colorectal Dis. 2012 Aug;14(8):e499-505. doi: 10.1111/j.1463-1318.2012.02991.x. |
| 15898604 | Background | Nagell CF, Pedersen CR, Gyrtrup HJ. [Complications after stoma closure. A retrospective study of 11 years' experience]. Ugeskr Laeger. 2005 Apr 18;167(16):1742-5. No abstract available. Danish. |
| 30483884 | Background | Baastrup NN, Hartwig MFS, Krarup PM, Jorgensen LN, Jensen KK. Anastomotic Leakage After Stoma Reversal Combined with Incisional Hernia Repair. World J Surg. 2019 Apr;43(4):988-997. doi: 10.1007/s00268-018-4866-5. |
| 34943616 | Background | Zarnescu EC, Zarnescu NO, Costea R. Updates of Risk Factors for Anastomotic Leakage after Colorectal Surgery. Diagnostics (Basel). 2021 Dec 17;11(12):2382. doi: 10.3390/diagnostics11122382. |
| Reset | Jun 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 17, 2023 | Jan 3, 2024 | |||
| Jan 4, 2024 | Jun 14, 2024 |
| ID | Term |
|---|---|
| D045823 | Ileus |
| D057868 | Anastomotic Leak |
| D007415 | Intestinal Obstruction |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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