Study on using omentum (Fat tissue near stomach) to encircle the new junction between the remanant food pipe and stomach in the neck after removal of the foor pipe for cancer, in order to improve postoperative healing and reduce Complications.

OMentum Around Neck Anastomosis (OMANA) trial- A phase II, prospective, single-arm interventional trial of omental wrapping around cervical esophagogastric anastomosis after esophagectomy - OMANA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/096787

Enrollment

Registered

2025-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C390- Malignant neoplasm of upper respiratory tract, part unspecified

Interventions

Intervention1: McKeown total esophagectomy with cervical esophagogastic anastomosis: Eligible and recruited Patients will undergo thoracic esophageal mobilization after conforming operability either

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing McKeown esophagectomy with a stapled and or hybrid and or handsewn anastomosis in the neck Written informed consent form

Exclusion criteria

Exclusion criteria: Retrosternal route of reconstruction Conduits other than stomach Previous gastric, pancreatic, colonic or splenic surgery that would have violated the omentum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with anastomotic leak, defined as full thickness gastro intestinal defect involving esophagus, anastomosis, staple line, or conduit irrespective of presentation or method of detection as set by ECCG (Esophagectomy complications consensus group), identified clinically/radiologically. This will be analysed in the intent to treat as well as per protocol populationsTimepoint: At the time of surgery	—

Measure

Time frame

Proportion of patients with anastomotic leak, defined as full thickness gastro intestinal defect involving esophagus, anastomosis, staple line, or conduit irrespective of presentation or method of detection as set by ECCG (Esophagectomy complications consensus group), identified clinically/radiologically. This will be analysed in the intent to treat as well as per protocol populationsTimepoint: At the time of surgery

—

Secondary

Measure	Time frame
Mean Intraoperative blood lossTimepoint: After surgery;Median Duration of surgery Timepoint: After surgery;Incidence of major postoperative complication as defined by Clavien Dindo classification (CD greather than II) Timepoint: After surgery;30-day post operative mortality expressed as a percentageTimepoint: After Surgery;90-day post-operative mortality expressed as a percentage Timepoint: After Surgery;90 day anastomotic stricture rates expressed as a percentage(patients presenting with symptom of dysphagia at follow up within 90 days will be subjected to a esophagogastroduodenoscopy to assess for anastomotic stricture) Timepoint: After surgery	—

Measure

Time frame

Mean Intraoperative blood lossTimepoint: After surgery;Median Duration of surgery Timepoint: After surgery;Incidence of major postoperative complication as defined by Clavien Dindo classification (CD greather than II) Timepoint: After surgery;30-day post operative mortality expressed as a percentageTimepoint: After Surgery;90-day post-operative mortality expressed as a percentage Timepoint: After Surgery;90 day anastomotic stricture rates expressed as a percentage(patients presenting with symptom of dysphagia at follow up within 90 days will be subjected to a esophagogastroduodenoscopy to assess for anastomotic stricture) Timepoint: After surgery

—

Countries

India

Contacts

Public ContactDr Karthik V

Tata Memorial Hospital

karthik290389@gmail.com7738922377

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026