No registrations found.
ID
Source
Brief title
Health condition
Benign gynaecological conditions (vaginal blood loss, endometrial abnormalities, cysts, myomas, endometriosis etc) which can be operated laparoscopically
Benigne gynaecologische aandoeningen (vaginaal bloedverlies, afwijkingen aan endometrium, myomen, cystes, endometriose enz) welke laparoscopisch geopereerd kunnen worden
Sponsors and support
Intervention
Outcome measures
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
operation duration
Background 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.
Study objective
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.
Study design
- 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.
Intervention
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.
Nadine Weijermans
Gynaecology and Obstetry
Heerlen 6419 PC
The Netherlands
n.weijermans@zuyderland.nl
Nadine Weijermans
Gynaecology and Obstetry
Heerlen 6419 PC
The Netherlands
n.weijermans@zuyderland.nl
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
o
Essure verwijdering
o
Figo 1-2 (t/m stadium 2)
endometrium carcinoom
-
Kan informed consent lezen en ondertekenen
Exclusion criteria
malignant diseas with metastasis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6242 |
NTR-old | NTR6422 |
Other | METC Zuyderland Heerlen : 17-N-74 |