Single-stapled Double Purse-string Technique for Colorectal Anastomosis

Not Applicable

Active, not recruiting

• Conditions: Colo-rectal Cancer
• Interventions: Procedure: SIA

• Registration Number: NCT04223141
• Lead Sponsor: Vejle Hospital

Brief Summary

A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.

Detailed Description

In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Study Start: 2020-03-17
• Primary Completion: 2022-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

• Not legally competent and/or < 18 years old
• Not able to comprehend information and/or give written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	SIA	Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique

Primary Outcome Measures

Name	Time	Method
Technical success	30 days	Successful construction of anastomosis by double purse-string technique
Complications	30 days	Surgical complications graded by Clavien-Dindo
Mortality	30 days	Postoperative death

Secondary Outcome Measures

Name	Time	Method
Readmissions	30 days	Unplanned hospital admissions at least 24 hs after discharge
Medical complications	30 days	Medical complications graded by Clavien-Dindo and MESS
Blood loss	30 days	Estimated intraoperative blood loss in ml
Operation time	30 days	Duration of operation from incision to last skin stitch
LOS	90 days	Length of stay - number of days from day of operation to discharge

Trial Locations

Locations (1)

Vejle Hospital, Department of Surgery; 🇩🇰 Vejle, Denmark