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Trial registered on ANZCTR


Registration number
ACTRN12621000070831
Ethics application status
Approved
Date submitted
18/11/2020
Date registered
28/01/2021
Date last updated
7/06/2021
Date data sharing statement initially provided
28/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy of a pulmonary recruitment maneuver and closed drainage in reducing shoulder tip pain in women undergoing a total laparoscopic hysterectomy.
Scientific title
A four arm, multi-centered, randomized, blinded, placebo-controlled phase 2 study in gynaecological patients undergoing a total laparoscopic hysterectomy comparing Pulmonary RecruItment Maneuver with closed Drainage vs. closed drainage vs. pulmonary recruitment vs. placebo in reducing shoulder tip pain.
Secondary ID [1] 302699 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
PRIMeD
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Shoulder Tip Pain 319615 0
Condition category
Condition code
Surgery 317559 317559 0 0
Other surgery
Reproductive Health and Childbirth 318047 318047 0 0
Other reproductive health and childbirth disorders
Musculoskeletal 318048 318048 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants that meet the study exclusion inclusion criteria will be randomised into one of four study groups.

Group A - Participants will receive the combined treatment of closed drainage for 4 hours and the pulmonary recruitment maneuver.

Group B - Participants will receive the single treatment of closed drainage for 4 hours.

Group C - Participants will receive the single treatment of the pulmonary recruitment maneuver plus a sham drain.

Group D - Participants will receive the current standard of care (no treatment) plus a sham drain.

The method of entry into the patient’s abdomen will be left to the discretion of the surgeon.
The maximum number of ports allowed to complete the surgery will be four. Only one 10mm port will be allowed.

Intraabdominal pressure during the surgical procedure should not exceed 15mmHg and the maximum flow rate should not exceed 40ml/min.

Closed Drain method
The drain will be administered by the surgeon.

A 15cm Blakes drain will be inserted through one of the existing 5mm port sites at the end of the surgery if the patient is randomized to arm A or B of the study. The drain will be placed on low suction, sutured down at its proximal end and removed 4 hours later by the ward nurse.

Patient’s randomized to arm C or D of the study will have a sham drain tube placed beneath a strip of sterile gauze taped to the skin, with no intraperitoneal or subcutaneous insertion and removed 4 hours later by the ward nurse. Documentation will be provided to ward staff to ensure awareness of the presence of the sham drain tube.

Pulmonary recruitment maneuver
The pulmonary recruitment maneuver will be administered by the anaesthetist.

The pulmonary recruitment maneuver will involve a series of positive pressure ventilations after the completion of the laparoscopic procedure.

It will be restricted to a maximum of five inflations and to a positive ventilation pressure of 40 mmHg, with the patients placed in the Trendelenburg position (30º) and with the laparoscopic ports left open.

Post-operative assessment
The surgeon will note in the participant’s medical file that the Visual Analogue Scale (VAS) numerical score and 15-item Quality of Recovery questionnaire (QoR-15) are required to be completed approximately 24-36 hours after the start of the operation. The time of completion of these assessments must be clearly recorded on the assessment sheets.

A Study Coordinator will approach the participants the day after their operation to provide them with the VAS and QoR-15 for completion. The Study Coordinator will:

•Record the details of consultation, including the time, on the computer data sheet assessment (eCRF). The medical records will be used to assess adherence to the interventions.

•Book an appointment for follow-up consultation for 6 weeks’ time.

Intervention code [1] 318984 0
Prevention
Intervention code [2] 319022 0
Treatment: Surgery
Comparator / control treatment
The reference comparator is Group D.
Control group
Placebo

Outcomes
Primary outcome [1] 325605 0
Shoulder tip pain will be measured using the numberical / visual analogue scale, 24-36 hours after the patient has had a total laparoscopic hysterectomy .
Timepoint [1] 325605 0
Recorded 24-36 hours after total laparoscopic hysterectomy.
Secondary outcome [1] 388521 0
Incidence of intraoperative complications graded according to the Clavien Dindo classification.

Timepoint [1] 388521 0
At time of surgery
Secondary outcome [2] 388522 0
Incidence of post-operative complications to 42 days graded according to the Clavien Dindo classification
Timepoint [2] 388522 0
Post-operative complications up to 42 days post surgery.
Secondary outcome [3] 388523 0
The patient will complete a QoR-15 questionnaire to measure patient-reported quality of recovery, 24-36 hours after surgery, and again at 6 weeks post surgery.
Timepoint [3] 388523 0
24-36 hours post-surgery and at 6 weeks post surgery
Secondary outcome [4] 388524 0
Length of hospital stay will be ascertained from hospital records.
Timepoint [4] 388524 0
Up to 42 days from the intervention.
Secondary outcome [5] 388525 0
Incidence of hospital readmission will be ascertained from hospital records, consulting room records and at the final study visit.
Timepoint [5] 388525 0
42 days from the intervention.

Eligibility
Key inclusion criteria
1. All women aged 18 years and over undergoing total laparoscopic hysterectomy
2. American Society of Anesthesilogists (ASA) Score 1 or 2
3. Undergoing a total laparascopic hysterectomy for one of the following conditions:-
1. Abnormal uterine bleeding.
2.Early stage uterine cancer
3.Atypical hyperplasia
4. Uterine fibroids where the uterine size should not exceed 10cm.
5. Risk reducing surgery
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy
2. Endometriosis
3. Severe lung disorder
4. Pre-operative shoulder or neck pain
5. Chronic pelvic pain
6. Severe Cardiovascular disease
7. History of high intracranial pressure
8. Not proficient in English

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be implemented by using the central telephone (interactive voice response system).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generation of the allocation sequence will be by computer-generated random numbers.
The allocation sequence will be generated by the NHMRC Clinical Trials Centre, University of Sydney, and implemented by a telephone interactive voice response system (IVRS).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
N/A
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
All analyses will be on an “intention-to-treat” (ITT) basis and will be conducted by the DATaR Consulting (Western Australia) using STATA v14 software (StataCorp 4905 Lakeway Drive, College Station, Texas 77845 USA).
As per ITT methodology, no imputation for missing data will be performed and the number of analysed observations will be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17963 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [2] 17964 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [3] 17965 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 31837 0
6008 - Subiaco
Recruitment postcode(s) [2] 31838 0
6009 - Nedlands
Recruitment postcode(s) [3] 31839 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 307134 0
Charities/Societies/Foundations
Name [1] 307134 0
Australasian Gynaecological Endoscopy and Surgery (AGES) Society.
Address [1] 307134 0
PO Box 717 Indooroopilly
QLD 4068 AUSTRALIA
Country [1] 307134 0
Australia
Primary sponsor type
Hospital
Name
St John of God Subiaco Hospital WA
Address
Clinicial Trials Research Centre
12 Salvado Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 307714 0
None
Name [1] 307714 0
Address [1] 307714 0
Country [1] 307714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307246 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 307246 0
St John of God Health Care Human Research Ethics Committee (HREC)
C/o St John of God Subiaco Hospital
12 Salvado Road
Subiaco Western Australia 6008
Ethics committee country [1] 307246 0
Australia
Date submitted for ethics approval [1] 307246 0
11/01/2021
Approval date [1] 307246 0
10/02/2021
Ethics approval number [1] 307246 0

Summary
Brief summary
This study will compare four different techniques for reducing the incidence of shoulder tip pain after total laparoscopic hysterectomy. Shoulder tip pain occurs commonly after the procedure and although the exact cause is unknown, it is thought that the carbon dioxide (CO2) gas that is introduced into the abdomen to allow laparoscopic surgery to be performed safely may be the cause. We believe that by combining two techniques - closed drainage and the pulmonary recruitment maneuver - after surgery may allow CO2 gas to be removed more effectively from the abdomen and allow patients to experience less shoulder tip pain than if these techniques are used on their own or not used at all.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 106550 0
Dr Gandendra Raj Mohan
Address 106550 0
Gynaecology & Oncology Surgeon
148A Cambridge Street
WEST LEEDERVILLE WA 6007
Country 106550 0
Australia
Phone 106550 0
+61 8 9388 8141
Fax 106550 0
NA
Email 106550 0
raj.ganendra@gmail.com
Contact person for public queries
Name 106551 0
Dr Gandendra Raj Mohan
Address 106551 0
Gynaecology & Oncology Surgeon
148A Cambridge Street
WEST LEEDERVILLE WA 6007
Country 106551 0
Australia
Phone 106551 0
+61 8 9388 8141
Fax 106551 0
NA
Email 106551 0
raj.ganendra@gmail.com
Contact person for scientific queries
Name 106552 0
Dr Gandendra Raj Mohan
Address 106552 0
Gynaecology & Oncology Surgeon
148A Cambridge Street
WEST LEEDERVILLE WA 6007
Country 106552 0
Australia
Phone 106552 0
+61 8 9388 8141
Fax 106552 0
NA
Email 106552 0
raj.ganendra@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results