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Intraperitoneal Lavage for Reducing Pain in Laparoscopy

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
intraperitoneal washing with saline solution
No washing
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring pain, laparoscopy, washing, intraperitoneal irrigation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • all patients candidates tor hysterectomy, hysterectomy and annessiectomy, laparoscopic myomectomy;
  • ECOG Performance Status between 0 and 1;
  • ages between 18 and 70 years
  • no present or previous systemic neoplastic disease
  • signed informed consent to the operation and execution of the intraperitoneal wash procedure.

Exclusion Criteria:

  • pregnancy,
  • pre-existing coagulopathy, neurological or cognitive dysfunction,
  • previous or recent pelvic flogosis,
  • previous opioid intake for chronic pain,
  • previous abdominal surgery,
  • previous or current systemic neoplastic disease
  • concomitant ovarian and cervical gynecological disease,
  • intraoperative conversion from laparoscopy to laparotomy ,
  • intraoperative complications,
  • use of morphine in the postoperative period,
  • ECOG Performance Status >1.

Sites / Locations

  • Ethics Committee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A - Yes Washing (SL)

B- No Washing (NL)

Arm Description

In this group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity.

No washing was performed before the end of surgery

Outcomes

Primary Outcome Measures

pain
to evaluate the postoperative pain using VAS scale

Secondary Outcome Measures

infections
postoperative infections

Full Information

First Posted
September 18, 2017
Last Updated
December 17, 2021
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT03290521
Brief Title
Intraperitoneal Lavage for Reducing Pain in Laparoscopy
Official Title
The Role of Intraperitoneal Irrigation and Lavage With Normal Saline for Reduction of Postoperative Pain After Laparoscopic Hysterectomy and Myomectomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present study is to evaluate the role of intraperitoneal washing irrigation with saline solution at the end of laparoscopic hysterectomy or myomectomy in reducing perception of postoperative pain.
Detailed Description
Patients will be fully and accurately informed on the type of intervention and will sign a specific informed consent, in accordance with CBM standards, both for the intervention to which the patient will undergo both for the study in question. Randomization will be performed through a randomized randomization table generated by a computer. Patients will therefore be divided into two groups: A - Yes Washing (SL) B - No Washing (NL) Prior to surgery, hemoglobin and PCR values will be evaluated in the preoperative. Prior to the incision, an antibiotic prophylaxis will be performed with cefazoline 2gr intravenously. The intervention in both groups involves the periombelic cutaneous incision and the sub-umbilical band. Introduction of 10mm led trocar based on open technique. The introduction of optics and CO2 insufflation allows the macroscopic visualization of the endotominal organs. The investigators proceed with the introduction of 3 additional 3-lane trocar accessories in the left iliac fossa, right and overlaid iliac thorax. You will perform a hysterectomy possibly associated with annessiectomy or myomectomy according to the surgical indication. Careful hemostasis is carried out. In the SL group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity. The surgery ends with the closure of the band and the breasts cutaneous. The parameters measured during the operation are: operating time, amount of CO2 injected (L), pneumoperitoneal pressure (mmHg). The operator surgeon is always the same. In the postoperative period, the following parameters will be evaluated: hemoglobin, white blood cells, PCR, body temperature, recovery of intestinal activity, administration of toradol, paracetamol and possible morphine and postoperative postoperative pain, palpation, cough. The latter is evaluated through tables using the VAS visual scale: patients report the subjective characteristics of perceived postoperative pain by attributing a value of 0 (no pain) to 10 (worse pain than I can imagine). It assesses the occurrence of any complications in post-operative, infection and fever, which may require the patient's exclusion from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
pain, laparoscopy, washing, intraperitoneal irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will therefore be divided into two groups: A - Yes Washing (SL) B - No Washing (NL)
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - Yes Washing (SL)
Arm Type
Experimental
Arm Description
In this group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity.
Arm Title
B- No Washing (NL)
Arm Type
Experimental
Arm Description
No washing was performed before the end of surgery
Intervention Type
Procedure
Intervention Name(s)
intraperitoneal washing with saline solution
Intervention Description
intraperitoneal washing at the end of surgery
Intervention Type
Procedure
Intervention Name(s)
No washing
Intervention Description
no washing
Primary Outcome Measure Information:
Title
pain
Description
to evaluate the postoperative pain using VAS scale
Time Frame
17 months
Secondary Outcome Measure Information:
Title
infections
Description
postoperative infections
Time Frame
17 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients candidates tor hysterectomy, hysterectomy and annessiectomy, laparoscopic myomectomy; ECOG Performance Status between 0 and 1; ages between 18 and 70 years no present or previous systemic neoplastic disease signed informed consent to the operation and execution of the intraperitoneal wash procedure. Exclusion Criteria: pregnancy, pre-existing coagulopathy, neurological or cognitive dysfunction, previous or recent pelvic flogosis, previous opioid intake for chronic pain, previous abdominal surgery, previous or current systemic neoplastic disease concomitant ovarian and cervical gynecological disease, intraoperative conversion from laparoscopy to laparotomy , intraoperative complications, use of morphine in the postoperative period, ECOG Performance Status >1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Angioli
Organizational Affiliation
Campus Bio-Medico University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ethics Committee
City
Rome
ZIP/Postal Code
00128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Use of intraperitoneal washing to reduce postoperative pain in laparoscopy

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Intraperitoneal Lavage for Reducing Pain in Laparoscopy

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