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Role of intraoperative and postoperative fluid restriction on postoperative outcomes after esophagectomy â?? a prospective randomized controlled trial

Role of intraoperative and postoperative fluid restriction on postoperative outcomes after esophagectomy â?? a prospective randomized controlled trial - FRES

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/03/003496
Enrollment
324
Registered
2013-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- intraoperative and postoperative fluid restriction on postoperative outcomes after esophagectomy

Interventions

Intervention1: Restricted fluid administration: Perioperative fluid administration targeted at an hourly urine output of 0.5 ml/kg/hour Control Intervention1: Conventional (liberal) fluid administrati

Sponsors

Tata Memorial Hospital Dr Ernest Borges Marg Parel Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with biopsy or cytology proven (squamous or adenocarcinoma) esophageal cancer 2. Patients with staging investigations indicating operability 3. Surgical plan for total transthoracic or transhiatal esophagectomy 4. American Society of Anesthesiologists (ASA) grade I, II

Exclusion criteria

Exclusion criteria: 1. Patients with low performance status (ECOG score > 1) 2. Patients with pre existing renal or liver disease 3. Patients with ischemic heart disease 4. Patients below 18 years and above 70 years of age.

Design outcomes

Primary

MeasureTime frame
Pulmonary complications in the two groupsTimepoint: Pulmonary complications in the two groups

Secondary

MeasureTime frame
1. Need for postoperative ventilation 2. Duration of postoperative ventilation 3. Need for tracheostomy for pulmonary toilet 4. Need for frequent bronchoscopies (5) Timepoint: 1. Need for postoperative ventilation 2. Duration of postoperative ventilation 3. Need for tracheostomy for pulmonary toilet 4. Need for frequent bronchoscopies (5)

Countries

India

Contacts

Public ContactDrCS Pramesh

Tata memorial Cancer Hospital

cspramesh@gmail.com022-24177070

Outcome results

None listed

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