NCT04670952

Brief Summary

Standard Pressure Laparoscopic Cholecystectomy，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis. According to literature, low pressure laparoscopic cholecystectomy is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, the previous studies have presented controversial results. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

2.4 years

First QC Date

November 24, 2020

Last Update Submit

December 21, 2020

Conditions

Cholecystitis/CholelithiasisCholecystitis; GallstonePolyp Gallbladder

Keywords

low pressure; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Change of partial pressure of carbon dioxide（pCO2）

    Change of pCO2 in arterial blood gas test

    Within postoperative 30 days.

Secondary Outcomes (4)

  • operation time

    During surgery.

  • conversion rate to open surgery

    During surgery.

  • visual analogue scale (VAS)

    During postoperative 24 hours.

  • complication rate

    Within postoperative 30 days.

Study Arms (2)

Low Pressure Laparoscopic Cholecystectomy

EXPERIMENTAL

LPLC refers to "Low Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 10mmHg.

Other: Low Pressure Laparoscopic Cholecystectomy

Standard Pressure Laparoscopic Cholecystectomy

OTHER

This is taken as the control group. SPLC refers to "Standard Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 14 mmHg.

Other: Standard Pressure Laparoscopic Cholecystectomy

Interventions

Low Pressure Laparoscopic CholecystectomyOTHER

Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group.

Low Pressure Laparoscopic Cholecystectomy
Standard Pressure Laparoscopic CholecystectomyOTHER

Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.

Standard Pressure Laparoscopic Cholecystectomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-85;
  • Patients receiving laparoscopic cholecystectomy due to benign gallbladder diseases;
  • Older patient or accompanied by cardiopulmonary diseases (age\>60 years, hypertension, Diabetes Mellitus, coronary heart disease, arrhythmia, chronic bronchitis, emphysema, history of heart surgery, history of lung surgery, history of mediastinal surgery, asthma, et al);
  • Aged older than 60, with or without the above diseases;
  • American society of Aneshesiologists (ASA) II or higher;
  • Informed consent acquired.

You may not qualify if:

  • Having contraindication of laparoscopic operations;
  • History at epigastric surgery. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Tian F, Sun X, Yu Y, Zhang N, Hong T, Liang L, Yao B, Song L, Pei C, Wang Y, Lu W, Qu Q, Guo J, Zhang T, He X. Comparison of low-pressure and standard-pressure pneumoperitoneum laparoscopic cholecystectomy in patients with cardiopulmonary comorbidities: a double blinded randomized clinical trial. BMC Surg. 2024 Nov 6;24(1):348. doi: 10.1186/s12893-024-02606-w.

    PMID: 39506748DERIVED

MeSH Terms

Conditions

CholecystitisCholelithiasisGallstones

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Xiaodong He, Doctor

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Feng Tian, Doctor

CONTACT

+86-01069152600andytianfeng@126.com

Jun Lu, Doctor

CONTACT

+86-01069152601pumchtf@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
It will be single blinded. Operator, first assistant and data collector could not be blinded. Whereas patients, nurses, data analyzer, and those who have the access to the primary predictor will be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 17, 2020

Study Start

June 10, 2019

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

December 23, 2020

Record last verified: 2020-12

Locations

CN(1)