The role of 3D laparoscopic rectal surgery: a randomised controlled trial
| ISRCTN | ISRCTN59485808 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59485808 |
| Protocol serial number | N/A |
| Sponsor | Yeovil District Hospital NHS Foundation Trust |
| Funders | European Association of Endoscopic Surgeons, Karl Storz GmbH & Co |
- Submission date
- 09/12/2015
- Registration date
- 16/12/2015
- Last edited
- 10/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Public
Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom
Scientific
Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 2D vs. 3D laparoscopic anterior resection: a randomised controlled trial |
| Study objectives | Using 3D imaging reduces intra-operative technical errors enacted during laparoscopic anterior resection. |
| Ethics approval(s) | South Central Berkshire B Research Ethics Committee, 24/02/2016, ref: 16/SC/0118 |
| Health condition(s) or problem(s) studied | Rectal adenocarcinoma |
| Intervention | Patients will be identified at local colorectal Multi-Disciplinary Team meetings and outpatient clinics. Potentially eligible patients will be approached by GCP (Good Clinical Practice) trained staff with delegated responsibility at each centre, who will discuss the study with the patient and answer any questions. Patients will be given a written site specific participant information sheet to take away. If willing and eligibility is confirmed, written consent will be obtained and the patient randomised. All trial participating centres and trial surgeons are experienced in using 3D imaging systems. Centralised randomisation will take place at Yeovil Hospital Clinical Research Unit. Allocation into one of two groups will be determined using pre-prepared computerised random number generation (zero or one) to allocate in a 1:1 ratio: 1. Group 1 patients undergo laparoscopic anterior resection using a 2D imaging system. 2. Group 2 patients undergo laparoscopic anterior resection using a 3D imaging system. |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
The total number of technical errors during each operation. Each operation will be digitally recorded and analysed unedited by a blinded assessor using Objective Clinical Human Reliability Analysis (OCHRA) |
| Key secondary outcome measure(s) |
1. Total operating time |
| Completion date | 30/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 72 |
| Total final enrolment | 88 |
| Key inclusion criteria | 1. Patients diagnosed with adenocarcinoma of the rectum (<15cm from anal verge as measured by staging MRI ) 2. Scheduled to undergo elective laparoscopic TME/ partial mesorectal excision surgery with curative intent, with or without neo-adjuvant treatment and with or without defunctioning stoma formation 3. Written informed patient consent |
| Key exclusion criteria | 1. History of inflammatory bowel disease 2. Patients requiring abdomino-perineal excision or surgery without anastomosis 3. Advanced tumours involving adjacent organs (TNM5 T4aNxMx) 4. Surgery performed with palliative intent or under unplanned/emergency settings 5. Previous treatment (radiotherapy/abdominopelvic surgery) for endometrial, ovarian, prostate, bladder (TURBT ok), anal or vaginal cancer 6. Patient or surgeon refusal to enter study or accept randomisation result |
| Date of first enrolment | 02/01/2016 |
| Date of final enrolment | 30/03/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
Yeovil
BA21 4AT
United Kingdom
Guildford
GU2 7XX
United Kingdom
Frimley
GU16 7UJ
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2019 | 13/03/2019 | Yes | No |
| Results article | Factors predicting operative difficulty | 01/12/2019 | 10/01/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 24/03/2021 | No | Yes |
Editorial Notes
10/01/2023: Publication reference added.
24/03/2021: CRUK link added to results (plain English)
13/03/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
22/01/2018: The following changes were made:
1. Recruitment end date was changed from 01/12/2017 to 30/03/2018.
2. Overall trial end date was changed from 01/01/2018 to 30/04/2018.
3. Publication plan (presentation dates) updated.
15/12/2016: Cancer Help UK lay summary link added.
24/11/2016: Internal review.
24/03/2016: Ethics approval information added.
