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Completed

NCT Number: NCT04223141

Single-stapled Double Purse-string Technique for Colorectal Anastomosis

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.

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vejle Hospital, Department of Surgery

Vejle, DK7100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all must be fulfilled):

  • Verified cancer of the sigmoid colon
  • Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis
  • Operation with curative intent

Exclusion criteria

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

Treatment and study plan

SIA

Procedure

As indicated by arm description

Primary outcomes

  1. Technical success

    Time frame: 30 days

    Successful construction of anastomosis by double purse-string technique

  2. Complications

    Time frame: 30 days

    Surgical complications graded by Clavien-Dindo

  3. Mortality

    Time frame: 30 days

    Postoperative death

Secondary outcomes

  1. LOS

    Time frame: 90 days

    Length of stay - number of days from day of operation to discharge

  2. Readmissions

    Time frame: 30 days

    Unplanned hospital admissions at least 24 hs after discharge

  3. Operation time

    Time frame: 30 days

    Duration of operation from incision to last skin stitch

  4. Blood loss

    Time frame: 30 days

    Estimated intraoperative blood loss in ml

  5. Medical complications

    Time frame: 30 days

    Medical complications graded by Clavien-Dindo and MESS

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

Single-stapled Double Purse-string Anastomotic (SIA) Technique in Robotic Malignant Sigmoid Resections

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Jan 10, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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