|- candidate number||27232|
|- NTR Number||NTR6422|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-mei-2017|
|- Secondary IDs||17-N-74 METC Zuyderland Heerlen|
|- Public Title||Pressure|
|- Scientific Title||Pressure pneumoperitoneum And Relaxing agents to create Safety in laparoscopic Surgery and Reduce post operative painlevels” |
|- hypothesis||With help of the TOF watch, a reduction in muscle relaxation can be observed earlier. In this way, peroperative events (pain or contractions by the patient) can be prevented. Less peroperative events lead to less postoperative pain.
|- Healt Condition(s) or Problem(s) studied||Endometriosis, Laparoscopy, Myoma, Blood loss|
|- Inclusion criteria||- Female, 18yr and older |
- benign gynaecological laparoscopies and early staged malignancies
o Hysterectomy, o Cystectomy o Adnexextirpation o Tubectomy o Adhesiolysis
o Endometriosis removal o Myomectomy o sterilisation
Figo 1-2 (t/m stadium 2)
Kan informed consent lezen en ondertekenen
|- Exclusion criteria||malignant diseas with metastasis|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||22-mei-2017|
|- planned closingdate||31-aug-2017|
|- Target number of participants||20|
|- Interventions||TOF WATCH: this device will be placed at the hand of the patient. TOF scores are blinded from the surgeon and anesthesist. The rest of the surgery will be just as normal.
|- Primary outcome||TOF-scores (compared to peroperative events >> when the patient reacts) and Postoperative painlevels (shoulder, abdominal, other)|
|- Secondary outcome||nausea and vomiting|
lengt of hospital stay
|- Timepoints||- Degree of muscle relaxation measured during surgery using the TOF watch.|
- Postoperative pain measured during one week after surgery: 1hour and 3 hours post operatively, 3 times a day at day 1-3 and 1 time a day at day 4-7.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Nadine Weijermans|
|- CONTACT for SCIENTIFIC QUERIES|| Nadine Weijermans|
|- Sponsor/Initiator ||Zuyderland Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|Zuyderland Medical Center, Heerlen|
|- Brief summary||This study is a baseline measurement at gynaecologic laparoscopic surgeries. We want to know if gynaecologists and anaesthesiologists work according a specific protocols about intraperitoneal pressure levels, the level of neuromuscular blockade and painmedication. |
During surgery a TOF-watch is attached to the patient. The investigator fills out a self-developed data collection form: Items on this form are: Duration of surgery, medication (sleep- and pain medication, muscle relaxants), positioning of the patient, the intraperitoneal pressures, events dat occur durig surgery, Actions of the anaesthesiology nurse, TOF values.
After surgery patients receive a questionnaire were they have to fill out there postoperative pain levels: shoulder pain, abdominal pain and incisional pain. Further they have to fill out if they took pain medication, if they was any nausea or vomiting and if they took medication to prevent that. Measure moments are: 1hour and 3 hours post operatively, 3 times a day at day 1-3 and 1 time a day at day 4-7.
|- Main changes (audit trail)|
|- RECORD||17-mei-2017 - 26-jun-2017|