Lateral Invagination of the Colorectal Anastomosis by Double Stapling

Not Applicable

• Conditions: Sigmoid Diseases; Anastomotic Leak
• Interventions: Procedure: Doubled-stapled colorectal anastomosis

• Registration Number: NCT04553250
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

Anastomotic dehiscence is the most feared complication in colorectal surgery, occurring in 6.3% -13.7% in patients with pelvic anastomoses \[1-4\]. This complication significantly increases morbidity, mortality, costs, and generates a greater impact on quality of life. In addition, several studies point to an increased risk of locoregional recurrence \[5, 6\].

There are different risk factors for anastomotic dehiscence: some preoperative, such as malnutrition or obesity \[9\]; other intraoperative ones, such as hypoperfusion of the anastomotic tissue or the anastomotic technique; and others postoperative, such as some types of medication \[7\]. In colorectal anastomoses, there is some concern about the safety of the double stapling technique, since the extremes of the linear suture line (called "dog ears") and the number of staple lines have a direct relationship with the risk of dehiscence \[8-11\].

With the aim of reducing suture dehiscence rates, different intraoperative techniques have been developed, such as reinforcing the anastomosis with stitches, the use of indocyanine green \[12, 13\] or the application of anastomotic sealants \[14\], without finding a definitive solution. Recently, benefits have been published of using the double-staple colorectal anastomosis lateral invagination technique, with the aim of avoiding "dog ears" \[15-17\]. Several case series and retrospective comparative studies have shown a significant decrease in anastomotic dehiscence using this technique, with all the clinical and economic benefits that this entails \[15-17\]. In this sense, the present study aims to evaluate the effectiveness and safety of the lateral invagination technique of double-staple colorectal anastomosis in a randomized and controlled trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-17
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10
• Study Start: 2021-03-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 786

Inclusion Criteria

• Age> 18 years
• Indication of resection of the left colon, sigmoid or upper rectum
• Minimally invasive approach
• Open surgery approach
• Double staple colorectal anastomosis
• Signed informed consent for inclusion in the study

Exclusion Criteria

• Patients <18 years
• Pregnancy
• ASA> III
• Absolute contraindication for anesthesia
• Patients who receive more than 1 gastrointestinal anastomosis during the same procedure
• Planned multi-organ resection during the same procedure
• Urgent / emergent surgery
• Reinforced anastomosis after positive intraoperative leak test
• Patients with simultaneous application of debulking and HIPEC
• Crohn's disease or active ulcerative colitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional technique	Doubled-stapled colorectal anastomosis	In this group, double-staple colorectal anastomosis will be performed following the technique described by Lee et al: Prior to firing the endostapler, a suture will be placed on the rectal stump that includes both "dog ears". After the punch comes out of the endostapler, the point will be tied, which will invaginate the two corners of the staple line on the same punch. Subsequently, the endostapler will be closed and fired, including the "dog ears" in the anastomotic rims
Lateral invagination technique	Doubled-stapled colorectal anastomosis	In this group, the circular endostapler will be fired in a conventional way, that is, without having invaginated the two corners of the staple line.

Primary Outcome Measures

Name	Time	Method
Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days	30 days	anastomotic dehiscence diagnosis

Secondary Outcome Measures

Name	Time	Method
Rate of perioperative morbidity using the Clavien-Dindo classification.	30 and 90 days PO or in-hospital stay
Rate of hospital readmissions	30 days
Rate of surgical reinterventions	30 days
Rate of perioperative mortality	30 and 90 days PO or in-hospital stay
Duration of surgery	1 day
Duration of hospital stay	days
Rate of Stoma-free survival	1 year
Rate Stoma closure	1 year