Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
NCT ID: NCT06475911
Last Updated: 2024-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2023-10-23
2024-12-30
Brief Summary
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* Pancreaticoduodenectomy,
* Hemihepatectomy or greater with or without caudate lobectomy
* Extrahepatic bile duct resection
* Extended cholecystectomy
* Distal Pancreatectomy with or without splenectomy The primary Objective of the study would be to compare post operative major morbidities and early mortality (\<90 day) in major HPB surgeries done for cancer patients with and without peri-operative hyponatremia. (\<135mmoL/L). Development of systemic complications and long term outcomes (overall survival and disease free survival) will also be evaluated.
It will be an observational study consisting of both, a retrospective arm and a prospective arm. All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024 will be included in the study.
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Detailed Description
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Secondary objectives: To compare the following in patients undergoing major HPB surgeries for cancer in patients with and without peri-operative hyponatremia (\<135mmoL/L)
* Post operative Systemic complications and
* Long term outcomes
* OS- POD1 till death/ last follow up (30th Sep 2024).
* DFS- Surgical resection till first detected recurrence of cancer or last follow up (30th Sep 2024) without recurrence.
* Study design- Observational study- Retrospective and prospective.
* Study period- Data collection will be done from time of ethical clearance till 30th June 2024.
* Intervention - None
* Monitoring and assessment- Clinical profile of the patient and symptoms will be serially followed during the patients post operative OPD visits.
* STATISTICAL ANALYSIS:
1. Continuous variables- with Student t test and Mann Whitney U test as appropriate.
2. Categorical data - Chi square or Fischer exact test. Besides the above, appropriate analysis will be done at the time of final data analysis.
3. Significance will be seen at 5 % level (p\<0.05).
4. Adequate subgroup analysis and multivariate regression analysis will be done.
* Adverse effects - No adverse effect is expected to occur out of the study protocol.
* Stopping rule - Not Valid
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Perioperative Hyponatremia
Perioperative Hyponatremia \<135 mEq/L
No interventions assigned to this group
No Perioperative Hyponatremia
No Perioperative Hyponatremia, i.e s.sodium \>135 mEq/L
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients with peri-operative diarrhea and vomiting due to infective cause leading to hyponatremia.
3. Patients who did not have a preoperative serum sodium level recorded within 72 hours prior to surgery.
4. Minor HPB cases.
18 Years
80 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ILBS-Cancer-01
Identifier Type: -
Identifier Source: org_study_id
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