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Comparison of effects of early against conventional tube removal in decreasing the complications after pancreas and small intestine surgery

Early versus Conventional drain removal in reducing the overall postoperative morbidity in patients undergoing Pancreatoduodenectomy - A Randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036527
Enrollment
86
Registered
2021-09-15
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: K00-K95- Diseases of the digestive system Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Patients drain removed on POD 3 (early drain removal group) : After assessing the drain fluid amylase and if the patients are within the study criteria- Patients drain will be removed o

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients who undergo Pancreatoduodenectomy with drain fluid amylase on POD 1 ( <5000IU/L) and POD 3 ( <350IU/L) in the department of General Surgery and Surgical Gastroenterology JIPMER

Exclusion criteria

Exclusion criteria: 1. Less than 18 years 2. Early Post Pancreatectomy haemorrhage [Defined as onset 3. Re-laparotomy within 72 hours from index operation 4. Sinister appearance of drain effluent (pancreatic juice) 5. Clinical suspect of biliary fistula 6. Peripancreatic fluid collection > 5cm (max diameter) at a routine transabdominal USG before randomization. 7. Surgeons decision for keeping the drain ( >POD3) in study group for whatever reasons.

Design outcomes

Primary

MeasureTime frame
To compare the length of hospital stay (LOS) between the early drain removal and conventional drain removal group in patients undergoing pancreatoduodenectomy.Timepoint: To compare the length of hospital stay (LOS) by assessing on day 3, 10 and 30 (if not discharged)

Secondary

MeasureTime frame
i) To compare the Pancreatic fistula rates among two groups ii) To compare the rate of Intra abdominal collections among two groups iii) To compare the Delayed gastric emptying rate among two groups iv) To compare the rate of Gastrointestinal bleeding among two groups. Timepoint: i) To compare the Pancreatic fistula by day 10 and day 30 ( if not discharged) ii) To compare the rate of Intra abdominal collections by day 10 and day 30 ( if not discharged) iii) To compare the Delayed gastric emptying rate by day 10 and day 30 ( if not discharged) iv) To compare the rate of Gastrointestinal bleeding by day 10 and day 30 ( if not discharged)

Countries

India

Contacts

Public ContactDR RAJ KUMAR NAGARAJAN

JIPMER

raj.jipmer@gmail.com9443292979

Outcome results

None listed

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