Consent and Quality of Information for Patients in Laparoscopic Surgery at the Academic Hospital Point “ G ” ( Mali )

Objectives: To evaluate the quality of the information provided to patients for their consent to be operated laparoscopically in the “A” surgery service of Point “G” University Hospital in Bamako (Mali). Methodology: The study was transversal, descriptive and prospective from November 1, 2016 to December 31, 2017 (14 months). It was performed at the general and laparoscopic surgery department of the Point “G” University Hospital in Bamako. Laparoscopically operated patients in scheduled or emergency programm whom consented the study and answered the questions before and after the surgical procedure were included. Results: One hundred patients were retained. The sex ratio was 4.2 for women. The surgery was scheduled in 93% (programmed surgery) of cases versus 7% (urgent surgery). Gynecological and obstetric surgery was performed in 54%, digestive surgery in 43% and laparoscopic exploration in 3%. The information was provided by surgeons, anesthetists, fellowship and students in respectively 63%, 6%, 11% and 9%. The reflection period before consenting to the act was greater or equal to 3 days in 90%. The media used were found to be suitable in 62%. The information was considered satisfactory preoperatively in 54% and postoperatively in 88%. Patients wanted additional information on post-surgery outcomes in 21%. Conclusion: The establishment of an information system and a free and informed consent form is a prerequisite for the quality of care in laparoscopic surgery.


Introduction
Laparoscopic surgery started in Mali in 2001.It became in the surgical context of surgery "A" service an alternative to the classic laparotomy for the management of many surgical diseases [1].
Despite its reputation for safety, it is very dependent on technology accompanying it and its practice remains subject to risks that are multifactorial.Patients operated by laparoscopy often have little information on the benefits, risks, existence of other therapeutic alternatives and the possibility of laparo-conversion.
The doctor must give loyal, clear and appropriate information to the person whom he examines, treats or advises about his state, the investigations and the care that he proposes to him.Throughout the illness, he must considerer the patient's personality in his explanations and ensures their understanding [2].
The patient's charter of October 6, 2008 in its article 13 in Mali, states that information provided to the patient must enable him to obtain a complete overview of all the medical and other aspects, of his condition and to take himself the decisions or to participate in decisions that may affect their well-being [3] [4].It is the physician's responsibility to prove that he has performed this obligation.
The purpose of this work is to evaluate the quality of the information provided to patients for their consent to be operated laparoscopically in the "A" surgery department of the academic hospital point "G" in Bamako (Mali).

Methodology
The study was transversal, descriptive and prospective from November 1, 2016 to December 31, 2017 (14 months).It was performed in the general and laparoscopic surgery department of the point "G" University Hospital in Bamako.
Laparoscopically operated patients in scheduled or emergency programm whom consented the study and answered the questions before and after the surgical procedure were included.Patients operated by conventional means or other techniques and those who did not consent were not selected.
The laparoscopic approach consisted of a consultation of anesthesia following a standard assessment of operability and a summary preparation of the patient according to the surgical context.
The information was provided by the surgeon, the doctors in training or anyone with the competence to do it.It consisted essentially of a description of the procedure, the expected benefits, the risks involved, the possibility of conversion to laparotomy and the existence of other therapeutic alternatives.Explicit informed consent was obtained from patients or their families before each intervention.
The equipment used was a laparoscopic column with instrumentation made of devices that were mostly reusable.Patient installation was dependent on the type of intervention.Anesthesia was general in type with intubation and curarization.The laparoscopic open was the rule to introduce the optical trocar with a foam-tipped mandrel.The number and position of the trocars depended on the diagnosis and the operating difficulties.Surgical Science The data collection was done from an elaborate questionnaire; the confidentiality and anonymity of the patients were respected.

Results
One hundred patients were selected according to the study criteria.The sex ratio was 4.2 for women.The age group from 30 to 39 years was the most represented with 36%.Among the occupations, housewives were 59% and civil servants 11%.The consent was given by the patient himself in 94% and in 6% by a legal representative.The literate patients including Koranic studies with a primary education level or above were 86%.The patients came from Bamako in 84% and had consulted according to another person or had been referred in 94%.The patients were operated on elective surgery in 93% versus 7% urgently.Surgical procedures were performed in a context of gynecological and obstetrical surgery in 54%, digestive surgery in 43% and laparoscopic exploration in 3%.The information was provided by the surgeons during the consultation in 63%, the anesthetists in 6%, the fellowship in 11%, resident students in 9%, the nurse responsible of the service in 7% and unspecified source in 4%.The cumulative information provided by two or more health workers was found in 24% with a discrepancy of 3%.The reflection period before consenting to the act was equal or more than 3 days in 90%.The information was considered sufficient to understand the disease and the nature of the surgical procedure by 12% of patients before admission to the service.The media used for the transmission of information were considered suitable in 62%, unsuitable in 38%.After medical visit this information regardless of the informant's qualification was considered satisfactory in 54%, acceptable in 38% and insufficient in 8%.In 23% the patients wanted more information.The quality of information judged by socio-demographic characteristics is described in Table 1.The quality of information according to the informant's qualification is described in Table 2.The information was considered satisfactory preoperatively in gynecological and obstetrical surgery in 51%, in digestive surgery it was 22%.The quality of the information given on the various characteristics related to the disease is summarized in Table 3.After laparoscopic surgery 21% of patients wanted more information on the results obtained and 17% judged the information received preoperatively inadequate.Before discharge, 88% of patients were generally satisfied with the quality of information on the different aspects of the disease from diagnosis to management.Table 4 summarizes the quality of information on postoperative therapeutic aspects

Discussion
In Mali there is a lack of legal bases dealing explicitly with consent in all it news aspects according to the literature of Western countries [4] [5] [6].Despite the multitude of published works on consent, very few can be compared to this study.The realities reported by respondents in the context of laparoscopic surgery may not reflect those experienced by laparotomy patients.Moreover, the study does not include the opinion of the surgeons of the service relatively to free and informed consent.There were more women with a sex ratio of 4.2 in relation to gynecological and obstetric pathologies.The age group from 30 to 39 years was the most represented with 36%.In the study of Williams et al. [7] in New Zealand, patients aged 64 were the most frequents.Surgical indications were dominated by gynecological and obstetric pathologies in 54%.This predominance could be explained by the expertise of the service motivating a strong solicitation in the management of adnexal pathologies (in the context of infertility), extra uterine pregnancies and intraperitoneal foreign bodies (intra-uterine device migration, textilum).Indications in digestive surgery were found in 43% with cholecystectomies, appendectomies and liver abscess surgery.These procedures are the most regularly performed in laparoscopy in our work context.The laparoscopic explorations were carried out as part of the diagnostic assessment of chronic abdominal or pelvic pain of unknown etiology but also for staging in the local evaluation of neoplastic pathologies.The patients were operated on 93% in elective surgery, which allowed them to have a reflection time equal or more than 3 days in 90% before consenting to the act.
In 12%, patients stated that they had prerequisites for understanding the disease and for laparoscopic surgery before taking them into the service.This information was provided during consultations by other health professionals who motivated their referral in the service.In the study of SANOGO Z.Z [8], 97.7% of the operated patients were referred by gynecologists.It is the responsibility of the professional or the health facility to provide proof of the provision of appropriate information.For this a signed form of the patient must be archived in the medical file as a proof.It is neither sufficient nor obligatory, but essential in case of pursuit.For the traceability of the information transmitted, the media used were deemed appropriate in 62%, unsuitable in 38% which reflects the application of the integrated service charter in the care of

Table 2 .
Informations and qualification of informant.

Table 3 .
Informations and characteristics of the disease.

Table 4 .
Informations and post-operative aspects.