Intra-Corporeal Anastomosis Result in Quicker Return of Bowel Function/Earlier Discharge

NCT03862781 | Recruiting

• 1 other identifier: 2018-139
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Adult patients who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

Conditions

Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

• Return of bowel function

  Flatus and bowel motions

  up to 2 weeks

Secondary Outcomes (6)

• Inpatient length of stay

  up to 2 weeks

• Incision length

  Surgery date

• Postoperative narcotic use

  up to 2 weeks

• Surgical site infection

  up to 6 weeks

• Perioperative morbidity

  Baseline (Prior to surgery)

Study Arms (2)

Intra-corporeal

OTHER

Right Hemicolectomy

Procedure: Right Hemicolectomy

Extra-corporeal

OTHER

Right Hemicolectomy

Procedure: Right Hemicolectomy

Interventions

Right Hemicolectomy PROCEDURE

Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

Extra-corporeal; Intra-corporeal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients are those over 18 years of age who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis. Right colectomy will be defined as removal of the ascending colon, ligation of the ileocolic artery and vein, +/- removal of the terminal ileum, +/- removal of the proximal transverse colon, and +/- removal of the right branch of the middle colic artery and vein.

You may not qualify if:

• Pregnant women
• Additional colon resection is planned (i.e. left colectomy or proctectomy)
• Vulnerable populations such as prisoners or adults unable to give consent
• If the scheduled surgery is planned at Butterworth hospital (as to standardize the nursing care received postoperatively)
• Emergent cases
• Patients will be excluded from the study intra-operatively if:
• The procedure is converted to an open resection
• If a loop ileostomy is performed in addition to the right colectomy

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Spectrum Health Medical Group

Grand Rapids, Michigan, 49546, United States

RECRUITING

Study Officials

• James W Ogilvie, Jr., MS

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Central Study Contacts

kendra Selby

CONTACT

616-486-0281; kendra.selby@helendevoschidrens.org

Ellen Derrer

CONTACT

ellen.derrer@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients, nursing staff and the perioperative care team (physician assistants, residents) will be blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Surgeon

Model Details: After the participants have been consented to the study, the study coordinator will refer to the randomization schedule, and alert the surgeon whether creation of the anastomosis will be done in either an intra-corporeal or extra-corporeal fashion.

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: March 5, 2019
• Study Start: January 28, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)