Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study
NCT ID: NCT05753709
Last Updated: 2023-03-03
Study Results
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Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2022-01-01
2022-10-30
Brief Summary
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• 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:
1. EE: Conventional Hand-sewn end-to-end anastomosis, and
2. SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups:
1. HSSA: Hand-sewn side-to-side anastomosis
2. SSSA: Stapled side-to-side anastomosis
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:
1. Rates of major post-operative complications
2. Rates of short-term complications (within 30 days of surgery)
3. Rates of re-operation
4. Post-operative length of stay in the hospital
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EE
End-to-end anastomosis, done in a conventionally described hand-sewn technique using sutures
Hand sewn end-to-end anastomosis
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.
SSSA
Stapled side-to-side anastomosis of the stoma using a linear cutter stapling device
Stapled side-to-side anastomosis
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.
HSSA
Hand-sewn anastomosis of the stoma using suturing of bowel loops placed in a side to side orientation
Hand sewn side-to-side anastomosis
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.
Interventions
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Hand sewn end-to-end anastomosis
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.
Hand sewn side-to-side anastomosis
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Bleeding disorders
* Patients undergoing stoma reversal along with a concurrent abdominal surgery
* Rectal anastomosis
* Use of circular stapler for anastomosis.
ALL
No
Sponsors
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Sawai Mansingh Medical College
OTHER_GOV
Responsible Party
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Tanmay Agarwal
Junior Resident, Principal Investigator
Locations
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Sawai Mansingh Medical College and Hospital
Jaipur, Rajasthan, India
Countries
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References
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Stedman's Medical Dictionary. 27th ed. Baltimore: Lippincott Williams & Wilkins; 2000.
Turnbull RB, Weakley FL. St Louis: Mosby. Atlas of intestinal stomas. 1967;32-9.
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.
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.
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.
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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.
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.
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.
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.
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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.
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.
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.
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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.
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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.
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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.
Other Identifiers
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37/MC/EC/2021
Identifier Type: -
Identifier Source: org_study_id
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