NCT06667284

Brief Summary

The investigators received two female patients in the hospital who developed gastroduodenal intussusception following gastric plication procedure, requiring surgical treatment. Both patients presented with non-specific, atypical abdominal pain several months after the gastric plication. Both patients required surgical intervention, which included manual reduction of the plication followed by subtotal gastrectomy en bloc with Roux-en-Y reconstruction. In the second case, an Omega Brown anastomosis was performed, and a jejunostomy was created after the anastomosis in both patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 28, 2024

Last Update Submit

October 31, 2024

Conditions

Keywords

case reportgastric plication

Outcome Measures

Primary Outcomes (1)

  • Comparison of management strategies for gastro-duodenal intussusception following gastric plication.

    The investigators compare the outcomes of managing bowel obstruction and abdominal pain after each surgery. The Investigator use small bowel obstruction prediction score index

    12 weeks following end of treatment.

Study Arms (2)

Group a

ACTIVE COMPARATOR

Roux en y procedure

Procedure: Roux en y procedure

Group b

ACTIVE COMPARATOR

Omega Brown anastomosis

Procedure: Omega brown procedure

Interventions

subtotal gastrectomy en bloc with Roux-en-Y reconstruction, using TA 90 and GIA staplers. The length of the biliopancreatic limb was 50 cm, while the alimentary limb was 80 cm

Group a

Gastrojejunal anastomosis with jejunojejunal anastomosis

Group b

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients with gastro-duodenal intussusception following a gastric plication procedure.

You may not qualify if:

  • children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Coco D, Leanza S, Fiume I. Small bowel obstruction: a prognostic score index for surgery - a review. Prz Gastroenterol. 2022;17(3):177-182. doi: 10.5114/pg.2022.118454. Epub 2022 Aug 3.

    PMID: 36127935BACKGROUND

MeSH Terms

Conditions

Intussusception

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Yamen Madi, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General surgeon

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 31, 2024

Study Start

October 31, 2024

Primary Completion

December 31, 2024

Study Completion

January 15, 2025

Last Updated

November 4, 2024

Record last verified: 2024-10