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DOES LOW PRESSURE CREATED IN GYNAECOLOGICAL LAPAROSCOPIC SURGERIES YIELD BETTER POST OPERATIVE OUTCOMES AS COMPARED TO NORMAL PRESSURES

POST-OPEATIVE OUTCOME ANALYSIS OF LOW PRESSURE VERSUS NORMAL PRESSURE PNEUMOPERITONEUM IN LAPAROSCOPIC GYNAECOLOGICAL SURGERIES: A DOUBLE BLINDED RANDOMIZED CONTROL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033177
Enrollment
40
Registered
2021-04-28
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: - Health Condition 2: N00-N99- Diseases of the genitourinary system Health Condition 3: O- Medical and Surgical

Interventions

Intervention1: LOW PRESSURE: Following convenient method of sampling, sample size is 40 and 20 allocated in each arm Group 1: outcome analysis done in post operative period using low pressure pneumo

Sponsors

AIIMS Rishikesh
Lead Sponsor
DrAmrita Gaurav
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing laparoscopic gynaecological surgeries without other simultaneous procedures for benign causes who agree to participate in the trial and give their written consent for the same. 2. Ability to comply with the protocol. 3. Patients who are able to communicate and answer questions. 4. Adequate cardio respiratory, renal and liver functions and who will be fit to undergo surgery as assess by anaesthetic

Exclusion criteria

Exclusion criteria: 1. Malignant disease of uterus, cervix or ovaries/adnexa 2. Premalignant changes of uterus, cervix and adnexa 3. H/O severe cervical dysplasia 4. Pregnancy 5. Coagulation disorders 6. Patients having any contraindication for laparoscopic gynaecological surgeries.

Design outcomes

Primary

MeasureTime frame
Postoperative observation including: 1. Postoperative pain (p) 2. Postoperative ileus (i) 3. Days of hospital stay (hs) Intraoperative observation including: 1. Intraoperative gas consumption (g) 2. Amount of blood loss (b) 3. Duration of surgery (d) 4. Need to raise pressure (n) Timepoint: intra operative and 2 days post operative—

Secondary

MeasureTime frame
To compare the baseline socio-demographic characteristics of the two study groups (s). To assess the effect of confounding factors on post operative outcome by varying the intra operative pneumoperitoneum pressure in laparoscopic gynaecological surgeries. 1. Age (a) 2. Haemoglobin levels (h) 3. Presence of co-morbidities (c) 4. Patient receiving family support (f) Timepoint: intra operative and 2 days post operative—

Countries

India

Contacts

Public ContactDr Shivaani Arora

AIIMS Rishikesh

jaya_sunil@yahoo.com9997310120

Outcome results

None listed

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